Average Ratings 0 Ratings
Average Ratings 0 Ratings
Description
Qualitum is an innovative platform designed for computer system validation (CSV/CQV) specifically tailored for the regulated life sciences sector. It automatically generates IQ/OQ/PQ protocols, GAMP 5 classifications, and audit trails directly from primary documents such as URS, P&IDs, and SOP libraries, ensuring that each requirement is tracked comprehensively through a queryable graph that eliminates the need for traditional spreadsheet RTMs. The platform maintains strict adherence to ALCOA+ data integrity standards, monitoring every record instead of just samples, while allowing human reviewers to validate and approve the outputs produced by the agent. Qualitum operates on a single-tenant basis across AWS, Azure, or on-premises environments, empowering customers with control over their keys and prohibiting any training rights on customer data. It seamlessly integrates with existing systems of record, including Veeva, MasterControl, TrackWise, AVEVA PI, Tulip, and others, making it a versatile choice for organizations. Designed with the needs of Heads of Validation and validation consultancies in mind, it serves stakeholders in the pharmaceutical, biotechnology, and medical device industries. Interested parties can obtain a per-site annual license quote upon request, and a fixed-fee pilot program lasting 8-12 weeks is offered for a single system to facilitate an initial experience. This comprehensive approach ensures that organizations can achieve their validation goals efficiently while maintaining compliance in a highly regulated environment.
Description
Veeva Vault serves as a cloud-based enterprise content management solution designed specifically for the life sciences sector, effectively bridging content gaps within organizations to achieve global uniformity while still allowing for local autonomy. In the past, businesses were often required to use different applications for managing content and separate ones for handling related data. Veeva Vault distinguishes itself as the sole platform capable of integrating both content and data management seamlessly. This integration allows organizations to dismantle silos that exist at the system, site, and country levels, ultimately leading to more efficient workflows spanning commercial, medical, clinical, regulatory, quality, and safety functions. Furthermore, since all Vault applications utilize the same foundational platform, companies benefit from improved efficiency and compliance through a more cohesive document flow across various regions and departments. This ensures that content remains not only accessible but also up-to-date and relevant throughout the entire development and commercial life cycle, enhancing overall operational effectiveness. As a result, Veeva Vault empowers organizations to align their global strategies while still honoring local needs.
API Access
Has API
No
API Access
Has API
No
Screenshots View All
No images available
Integrations
BA Insight
No
Beefree
No
Bigtincan
No
ClinVigilant
No
DocShifter
No
Greenlight Guru Clinical
No
Knak
No
Lyriko
No
Salesforce Data 360
No
StackAI
No
Integrations
BA Insight
Yes
Beefree
Yes
Bigtincan
Yes
ClinVigilant
Yes
DocShifter
Yes
Greenlight Guru Clinical
Yes
Knak
Yes
Lyriko
Yes
Salesforce Data 360
Yes
StackAI
Yes
Pricing Details
No price information available.
Free Trial
No
Free Version
No
Pricing Details
No price information available.
Free Trial
No
Free Version
No
Deployment
Web-Based
Yes
On-Premises
Yes
iPhone App
No
iPad App
No
Android App
No
Windows
No
Mac
No
Linux
No
Chromebook
No
Deployment
Web-Based
Yes
On-Premises
No
iPhone App
Yes
iPad App
Yes
Android App
Yes
Windows
No
Mac
No
Linux
No
Chromebook
No
Customer Support
Business Hours
No
Live Rep (24/7)
No
Online Support
No
Customer Support
Business Hours
Yes
Live Rep (24/7)
Yes
Online Support
Yes
Types of Training
Training Docs
No
Webinars
No
Live Training (Online)
No
In Person
No
Types of Training
Training Docs
Yes
Webinars
Yes
Live Training (Online)
Yes
In Person
Yes
Vendor Details
Company Name
Qualitum
Website
qualitum.ai
Vendor Details
Company Name
Veeva Systems
Founded
2007
Country
United States
Website
www.veevasystems.com
Product Features
Product Features
Enterprise Content Management (ECM)
Archiving & Retention
Yes
Collaboration Tools
Yes
Content Lifecycle Management
Yes
Digital Asset Management
Yes
Document Management
Yes
Electronic Signature
Yes
Information Governance
Yes
Mobile Access
Yes
Search
Yes
Version Control
Yes
Workflow Management
Yes